327P Traditional Chinese medicine jianpi-bushen sequential formula modulating gut microbiota for stage II&III colon cancer patients during adjuvant chemotherapy: Results from a multi-center randomized double-blind placebo-controlled clinical trial in China

Abstract

TCM herbal medicine Jianpi-Bushen(JPBS) sequential formula is used to alleviate chemo-induced symptoms in China. However, there is still a lack of evidence on JPBS’s efficacy and mechanism for colon cancer (CC) patients during adjuvant chemotherapy. The current study aimed to analyze gut microbiota of CC patients who were treated by JPBS along with adjuvant chemotherapy. The original study was a randomized placebo-controlled clinical trial conducted in 13 different hospitals in China. Inclusion criteria included stage II or III colon cancer patients between age 18 and 80 who were receiving CapeOX adjuvant chemo after radical surgery. Eligible patients were randomly assigned (1:1) to orally take either JPBS or placebo granule twice daily during the whole period of chemo. Fecal samples were collected at five different visit times (V1: baseline, V2: six days after baseline, V3: one day prior to second cycle of chemo, V4: six days after V3, V5: one day prior to third cycle of chemo). Microbiome 16SrRNA analysis was preformed through Majorbio Cloud, an online bioinformation analysis platform. We collected 1240 fecal samples from 376 enrolled patients for 16S rRNA sequencing. In total, we got 87159119 high-quality sequences and obtained 14816 OTUs. The α diversity (ace index) of the gut microbiota community significantly increased (V2:V5, 591.2 vs. 526.1，p=0.044) in JPBS group, but there was no significant change in placebo group. The Venn diagram reflected the difference of OTUs in all groups, 2574 common OTUs were identified in all groups. On Genus level, Bacteroids, Escherichia-Shigella and Prebotella were predominated in the two groups, but the relative abundance was different. The Kruskal-Wallis H test found that the abundance of Fusobacteria was significantly decreased in JPBS group (P=0.017). In conclusion, JPBS could shift gut microbiota of CC patients during chemotherapy and decreased the abundance of pathogenic bacteria. In brief, our results suggested that JPBS could alleviate chemo-induced symptoms through gut microbiome modulating.